GIS · Test, Fibrinogen
Hematology · 21 CFR 864.7340 · Class 2
Overview
| Product Code | GIS |
|---|---|
| Device Name | Test, Fibrinogen |
| Regulation | 21 CFR 864.7340 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
Classification Rationale
Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set | Diazyme Laboratories | Jan 31, 2016 | SESE |
| K042919 | FIBROTEK FIB | R2 Diagnostics, Inc. | Nov 29, 2004 | SESE |
| K993482 | K-ASSAY FIBRINOGEN | Kamiya Biomedical Co. | Dec 6, 1999 | SESE |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | Ortho Diagnostic Systems, Inc. | Nov 29, 1996 | SESE |
| K941001 | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT | Diagnostic Specialties | Aug 30, 1994 | SESE |
| K925494 | BIOMERIEUX HEMOLAB FIBRINOMAT | Biomerieux Vitek, Inc. | May 18, 1993 | SESE |
| K923921 | IL TEST PT FIBRINOGEN HS | Instrumentation Laboratory CO | Oct 26, 1992 | SESE |
| K913061 | FIBRINOGEN DETERMINATION KIT | Sigma Diagnostics, Inc. | Oct 9, 1991 | SESE |
| K910636 | ABS CADKIT | Panbio, Inc. | Apr 29, 1991 | SESE |
| K903874 | FIBRINOTEST(TM) - FIBRINOGEN ASSAY | Haemachem, Inc. | Feb 14, 1991 | SESE |
| K881685 | FIBRINOGENTEST-O | Diatech, Inc. | Aug 9, 1988 | SESE |
| K881150 | KINETIC FIBRINOGEN ASSAY | Bio/Data Corp. | Mar 28, 1988 | SESE |
| K781880 | ASSAY KIT, THROMBO-SCREEN | Pacific Hemostasis | Dec 4, 1978 | SESE |
Top Applicants
- Bio/Data Corp. — 1 clearance
- Biomerieux Vitek, Inc. — 1 clearance
- Diagnostic Specialties — 1 clearance
- Diatech, Inc. — 1 clearance
- Diazyme Laboratories — 1 clearance
